Catalog Number

27-6209D

Brand Name

CARDINAL HEALTH

Version/Model Number

27-6209D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OIP

Product Code Name

Radiology-diagnostic kit

Public Device Record Key

fcd3cd9a-312c-47c0-a9b5-b9aa52f45e30

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Package DI Number

50195594722232

Quantity per Package

35

Contains DI Package

10195594722234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE